Pharma News

Genentech, a member of the Roche Group  announced the Phase III IMspire150 study, in people with previously untreated BRAF V600 mutation-positive advanced melanoma, met its primary endpoint of progression-free survival (PFS). The study showed adding Tecentriq® (atezolizumab) to Cotellic ® (cobimetinib) and Zelboraf® (vemurafenib) helped to reduce the risk of disease worsening or death, compared to placebo plus Cotellic and Zelboraf.

This news can bring smiles on the faces of all those people who are suffering from obesity-induced diabetes. A group of researchers from Council of Scientific and Industrial Research- Center for Cellular and Molecular Biology (CSIR-CCMB) have shown the role of a protein that is responsible in increasing insulin action in obesity-induced diabetes.

Sun Pharma Advanced Research Company Ltd. (SPARC) announced that Abraxis Bioscience LLC. has dismissed the patent infringement complaint filed against SPARC regarding SPARC's New Drug Application for PICS (Paclitaxel Injection Concentrate for Suspension).

Zydus Cadila takes yet another step towards diabetes care with the launch of an affordable oral anti-diabetic agent, Vinglyn (Vildagliptin) & Vinglyn M (Vildagliptin plus metformin). The drug belongs to the class of oral anti-diabetic agents, known as DPP4 inhibitors, which have shown promise in achieving glycaemic control without deterioration in beta cell function and are one of the recent advancements in diabetes care and management. Vinglyn and Vinglyn M will be marketed by Zydus Healthcare Ltd.

The U.S. Food and Drug Administration has warned Liveyon Labs Inc. (Liveyon Labs) and Liveyon LLC, of Yorba Linda, California, and their presidents and chief executive officers, Roya Panah and John W. Kosolcharoen, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO.

The number of pregnant women and children in sub-Saharan Africa sleeping under insecticide-treated bed nets and benefiting from preventive medicine for malaria has increased significantly in recent years, according to the World Health Organization’s World malaria report 2019.

The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards.

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ORENCIA® (abatacept) for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors. There are no approved therapies for the prevention of acute GvHD, a potentially life-threatening medical complication that can impact patients receiving such transplants for the treatment of certain genetic diseases and hematologic cancers.

AstraZeneca and MSD Inc., Kenilworth, N.J., US announced that the companies have received marketing authorisation from China’s National Medical Products Administration (NMPA) for Lynparza (olaparib) as a 1st-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.